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Recall Observatory FDA recall evidence

Drug product

NovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark NDC 0169-7501-90

D-0616-2021

March 22, 2021

Class I

Product summary

Firm
Novo Nordisk Inc
Event
Event 87537
Status
Terminated
Classification
Class I
Quantity
N/A
Official record key
drug-enforcement:D-0616-2021

Official wording

Reason: Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.

Code information: JZFC826 exp 06/30/2021; KZFM305 exp 08/31/2022

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.